DRYSTAR AXYS, MODEL EYZ4E


Device Classification Name

camera, multi format, radiological

510(k) Number K072680
Device Name DRYSTAR AXYS, MODEL EYZ4E
Applicant
AGFA HEALTHCARE CORPORATION
10 south academy st.
greenville, 
SC 
29601

Applicant Contact patrick j lynch
Correspondent
AGFA HEALTHCARE CORPORATION
10 south academy st.
greenville, 
SC 
29601

Correspodent Contact patrick j lynch
Regulation Number 892.2040
Classification Product Code
LMC  
Date Received 09/24/2007
Decision Date 10/25/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes

Recalls CDRH Recalls